Statutory sampling procedure for imported condoms must be followed; invalid testing report cannot sustain confiscation or penalty.

Imported condoms were found not liable to confiscation because the test report was invalid in law: the Drugs and Cosmetics Rules, 1945 required the bursting volume and pressure test to follow the sampling plan in Annexure III to Schedule R, but the prescribed sample size of 315 was not used and the laboratory tested only 45 pieces. As the statutory sampling procedure was not followed, the goods could not be treated as sub-standard on that report. Rule 141 also supported re-shipment, and the goods had in fact been re-exported. On that basis, confiscation and the consequential penalty were held unsustainable.

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Issues: Whether the imported condoms were liable to confiscation and penalty on the basis of the test report, and whether the prescribed sampling and testing procedure under the Drugs and Cosmetics Rules, 1945 had been followed.

Analysis: The goods were alleged to be sub-standard because one batch was not granted ADC NOC. The applicable framework required mechanical contraceptives to conform to Schedule R, and the bursting volume and pressure test had to be conducted in accordance with the sampling plan in Annexure III to Schedule R. For the relevant batch size, the prescribed sample size was 315, but the laboratory test was conducted on 45 pieces only. Since the statutory sampling method was not followed, the test report could not be treated as valid in law. The request for retesting was not considered. Rule 141 of the Drugs and Cosmetics Rules, 1945 also supported re-shipment, and the goods had in fact been re-exported.

Conclusion: The confiscation and consequential penalty were not sustainable. The goods were held not liable for confiscation, and the appeal succeeded with consequential relief.

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